PR1-Specific Cytotoxic T-Lymphocyte Infusion With Recurrent Chronic Myelogenous Leukemia (CML) After Allogeneic Hematopoietic Transplantation
Tracking Information | |||||||||
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First Received Date ICMJE | March 18, 2009 | ||||||||
Last Updated Date | November 29, 2011 | ||||||||
Start Date ICMJE | March 2008 | ||||||||
Estimated Primary Completion Date | March 2013 (final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
Maximally tolerated dose of donor PR1-specific cytotoxic T-lymphocytes (PR1-CTL) [ Time Frame: Continuous reassessment, infusion day 0 and second infusion day 60+/- 7 ] [ Designated as safety issue: Yes ] | ||||||||
Original Primary Outcome Measures ICMJE |
To find the highest safe dose of cells donated form a donor that can be given to treat leukemia in patients with CML. [ Time Frame: 2 Years ] [ Designated as safety issue: Yes ] | ||||||||
Change History | Complete list of historical versions of study NCT00866346 on ClinicalTrials.gov Archive Site | ||||||||
Current Secondary Outcome Measures ICMJE | |||||||||
Original Secondary Outcome Measures ICMJE | |||||||||
Current Other Outcome Measures ICMJE | |||||||||
Original Other Outcome Measures ICMJE | |||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | PR1-Specific Cytotoxic T-Lymphocyte Infusion With Recurrent Chronic Myelogenous Leukemia (CML) After Allogeneic Hematopoietic Transplantation | ||||||||
Official Title ICMJE | A Phase I Study of PR1-Specific Cytotoxic T-Lymphocyte Infusion for Patients With Recurrent CML After Allogeneic Hematopoietic Transplantation | ||||||||
Brief Summary | Primary Objective: To determine the maximally tolerated dose of donor PR1-specific cytotoxic T-lymphocytes (PR1-CTL) as treatment for relapsed or persistent chronic myelogenous leukemia (CML) after allogeneic hematopoietic transplantation from an HLA-matched related or unrelated donor. Secondary Objectives:
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Detailed Description | Before treatment starts, you will have a complete physical exam, including blood (about 2 tablespoons) tests. You will have a chest x-ray and bone marrow will be collected. To collect a bone marrow sample, an area of the hip or chest bone is numbed with anesthetic and a small amount of bone marrow is withdrawn through a large needle. Women who are able to have children must have a negative blood pregnancy test. You will be treated with donor immune cells (T lymphocytes) that will specifically target certain leukemia cells in your body. Each participant will receive two doses of donor cells, 60 days apart. The second dose will be given 60 days after the first dose, at a higher dose level, as long as no serious side effects occur after the first dose and there is still disease present. Four dose levels of PR1-specific T lymphocytes will be considered. Up to 30 patients will be treated in cohorts of 3, starting at the lowest dose level, and not skipping an untried dose level when escalating. The trial will be stopped early if the lowest dose level is found to be unacceptably toxic. These cells will be given on an outpatient basis. After each donor cell infusions, you will be followed once a week in the outpatient clinic for at least 1 month and then every 3 months for at least one year. You will have routine blood (about 2 tablespoons) and urine tests at these visits. Participants experiencing side effects from their leukemia or leukemia treatment may need to be hospitalized earlier. You will also receive several other medications to help decrease the risk of infections while your immune system is weak. These include preventative antibiotics, antiviral drugs, and antifungal drugs. Bone marrow samples will be taken before the second cell infusion, and then 8 weeks, 12 weeks, 6 months and 1 year after the second cell infusion. This is an investigational study. A total of up to 30 patients will be take part in this study. All will be enrolled at UTMDACC. |
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Study Type ICMJE | Interventional | ||||||||
Study Phase | Phase 1 | ||||||||
Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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Condition ICMJE | Chronic Myelogenous Leukemia | ||||||||
Intervention ICMJE | Biological: PR1-primed lymphocyte (PR1-CTL) Infusion
Two infusions of PR1-specific T lymphocytes (donor immune cells) 60 days apart. Starting infusion dose 1 x 106 nucleated cells/kg. Other Names:
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Study Arm (s) | Experimental: PR1-CTL
PR1-primed lymphocyte (PR1-CTL) Infusion (PR1-specific T lymphocytes)
Intervention: Biological: PR1-primed lymphocyte (PR1-CTL) Infusion |
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Publications * | |||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Active, not recruiting | ||||||||
Estimated Enrollment ICMJE | 30 | ||||||||
Completion Date | |||||||||
Estimated Primary Completion Date | March 2013 (final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria: None. |
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Gender | Both | ||||||||
Ages | |||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
Location Countries ICMJE | United States | ||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT00866346 | ||||||||
Other Study ID Numbers ICMJE | 2003-0564 | ||||||||
Has Data Monitoring Committee | No | ||||||||
Responsible Party | M.D. Anderson Cancer Center | ||||||||
Study Sponsor ICMJE | M.D. Anderson Cancer Center | ||||||||
Collaborators ICMJE | |||||||||
Investigators ICMJE |
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Information Provided By | M.D. Anderson Cancer Center | ||||||||
Verification Date | November 2011 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |